Gastroenterology and Medical Ethics

Basic moral principles and rules of medical ethics are as old as the medical profession itself. They were succinctly formulated in such codes as the Hippocratic Oath and Maimonides' Prayer, and have served for centuries as an unchanged moral base for medical practice. Major social and moral changes, particularly those of the second half of the 20th century, have challenged many of these classical values and modified others: witness the introduction of new attitudes toward sexuality and developments in transplantation of human tissues and organs, and opposing views on abortion. Promotion of the patient's autonomy and of human rights has led to the firm establishment of the right of the individual patient to be fully informed and consulted on all medical considerations and decisions related to his or her well-being, health and even death. The influence of such professionals as philosophers, ethicists, sociologists, anthropologists and lawyers has altered concepts of the patient-doctor relationship.

The change from a classical paternalistic to a modern participatory patient-doctor relationship has significantly altered the pattern of medical practice. When a patient consults a physician, a contractual arrangement takes place. The patient provides the physician with the personal, intimate information necessary for proper evaluation and rational management. Complete patient care must take into consideration the patient as a total person, including his or her personal moral values.

The rapid expansion of medical knowledge and technology has also introduced a range of expensive, complex, and often aggressive diagnostic and therapeutic procedures. The rising costs of many new, highly skilled, labor-intensive techniques have led to the rationing of our progressively diminishing health-care resources and raised difficult questions of fairness and priorities: who gets what and why, at whose expense, and under what circumstances?

Application of current biomedical ethical principles to the changing clinical and social situation has thus become an essential part of the practice of modern medicine (Table 1).

Gastroenterologists share common ethical principles with and encounter problems similar to those faced by their colleagues in other medical disciplines. Like other specialists, gastroenterologists must often apply general medical ethical principles to specific areas of their activities. One such area is diagnostic and therapeutic endoscopy. Others include the treatment of patients with new, potent drugs, the active participation of gastroenterologists in drug trial studies, and their relationship with industry.

Transplantation of the liver, intestine and pancreas also raises ethical issues, particularly related to economy of resources. The demands that organ transplantation places on society lead to political rather than purely medical decisions concerning the allocation of resources and assignment of priorities. These decisions are not only based on the principle of individual beneficence, but they also are greatly influenced by social perceptions of justice and fairness. Gastroenterologists are being exposed to escalating pressure to control costs, ration resources and act as gatekeepers for organ transplantation. In addition to purely medical decisions, assessing patient suitability involves ethical issues. Should, for example, an individual with self-induced liver disease from abusing alcohol or other drugs, or from following a particular lifestyle, be accepted for transplantation?

Commerce involving organs or parts of organs is another area of ethical concern. Organ sale elsewhere in the world has been justified in that it is the only way to meet current needs. The issue is clouded by a lack of absolute ethical standards that could be uniformly applied in all parts of the world. Although medicine is generally transcultural, ethics is often culture-specific, as it depends on historical, religious, social and cultural factors. Ethical principles applicable to contemporary Western societies do not apply to parts of the world with completely different cultural and social traditions.

The availability of cadaveric organs is the main limiting factor in adult liver transplantation in Canada. According to a recent study, at least 37 patients died in Canada in 1991 while waiting for a new liver.

The Council on Ethics and Judicial Affairs of the American Medical Association has recommended a system of mandated choice, in which "everyone would be asked whether they consent to organ donation."

The Council of Europe has adopted a policy in 13 countries of "presumed consent" in which the onus is placed on the individual to opt out of cadaveric organ donation.

No such system exists in Canada. Canadian physicians therefore find themselves morally responsible for ensuring that no potentially available organ is wasted. Accordingly, a failure to secure such an organ, either by discouraging a donation as a result of personal bias, or failing through a passive attitude to consider the possibility and appropriateness of timely retrieval of a patient's organs, amounts to withholding a potentially lifesaving treatment from a waiting recipient.

The advent of fiberoptic endoscopy has had a major impact on research and clinical practice in gastroenterology. Ethical issues peculiar to gastrointestinal endoscopy are often not obvious. Gross violations of a code of ethics are easily detected and identified. The difficulty arises, however, when assessing skill, competence and quality control. It is often difficult to draw a clear line between professional competence and the safety of a procedure on one hand, and ethical behavior on the other.

Ethical considerations arising from invasive diagnostic and therapeutic gastroenterological procedures have been recently addressed in Canada by the Canadian Association of Gastroenterology in its consensus report "Consensus in Endoscopy." The patient's informed consent, based on a full understanding of risks and benefits, must be obtained prior to the procedure and sedation. While society's resources should be economically utilized, economic constraints should not adversely influence the quality of the care.

In addition to mandatory training requirements, the physician's technical and cognitive skills must be maintained through strict adherence to specified standards and must be further improved through constant learning.

Performance of endoscopic procedures in excess of diagnostic and therapeutic requirements and beyond the needs of approved research is unethical.

An innovative procedure or a significant modification of a standard procedure cannot be undertaken without prior approval by the institutional review board or the hospital ethics committee, and without the fully informed consent of the patient.

Life-support measures that provide nutrition through a variety of oral, enteral and parenteral routes have become the principal form of treatment of not only critically ill patients, but often also patients who are terminally ill.

Nonetheless, the belief that nutritional support is beneficial to terminally ill patients has been recently questioned.

Recent reports provide increasing evidence that withholding artificial nutrition and hydration is actually devoid of suffering, providing that oral food and liquids are given as requested by the patient and that proper care is taken of mouth and lips. While insufficient to maintain the patient's weight and life, this limited nutrition and hydration keeps the patient comfortable.

Since food and water have a strong emotional connotation as the essence of life, any attempt at withholding these is strongly resisted by care-givers. Furthermore, some physicians may not only try to persuade but may also resort to coercion and force a patient to accept a given form of artificial feeding. Strong ethical arguments are nevertheless being put forward that prolonging the life of a terminally ill patient through artificial nutrition and hydration prolongs suffering and delays the natural process of death. It therefore violates the ethical principle of beneficence and nonmaleficence. When carried out against the patient's expressed wish or through coercion it also violates the principle of autonomy.

Close cooperation between the pharmaceutical industry and the medical profession has greatly contributed to recent progress in research and to educational opportunities. The development of new drugs requires clinical trials. Development of a new drug from the initial invention of a chemical structure until its final approval for general use takes an average of 10 to 15 years and may cost up to $100 million before realizing any financial return. The industry is quite aware that commercial objectives must not override ethical considerations and has developed the guidelines governing the conduct of such studies. By subscribing to such codes, the industry has accepted responsibility for proper monitoring and supervision of sound clinical trials. For their part, those physicians involved in a clinical study must possess adequate knowledge and devote the necessary time to ensure that no breach of ethical principles occurs.

It is unethical to enter a patient into a trial unless the investigator truly believes that the new drug or procedure will provide benefits beyond those already available. The investigator must be free to publish the results regardless of the outcome, unencumbered by the private interests of the sponsor. The principal investigator shares with the sponsor the responsibility for the scientific validity, ethical content and correctness of the clinical evaluation of the product undergoing trial. The investigator may be remunerated for clinical work (such as physical examination, endoscopies and other technical procedures) if charged for at standard rates. It is unethical, however, to derive personal financial benefit as a reward for participating in or conducting the study.

Medical research using human subjects requires careful scrutiny. A recent study by an international group of reviewers found that a significant proportion of studies involving humans, and published in some of the leading gastroenterology journals, failed to meet ethical standards as defined by the reviewers. Approximately 40% would have been rejected by reviewers had they been members of the review boards at the institutions where the work was done. Some 12% of these "rejections" involved perceived danger to participating patients; the remainder involved poor study design or problems of statistical analysis. Between 10 and 15% of medications used were subsequently discovered to be potentially toxic.

There seem to be several places where a potential deficiency may originate. Concern about personal career development and academic pressure to demonstrate research productivity might induce an investigator to disregard what might at first appear to be a trivial issue. Casual supervision and inadequate quality control by senior, experienced and established investigators could be another factor. Poorly conducted research leading to faulty conclusions based on avoidable deficiencies and errors is unethical. Just because a project has received the approval of an institutional review board, there is no guarantee that it will remain ethical throughout. Finally, the system of peer review, the traditional method of ensuring the quality of scientific investigation, is not infallible. Close supervision based on clearly defined institutional publication policies and periodic careful review of the study's progress may eliminate many of these ethical pitfalls. The ethical component must be part of the scientific review.

The complexity of current scientific, technical, philosophical and social developments and other conditions in the second half of the 20th century present a plethora of ethical issues that we need to consider in our daily work - clinical practice, research or teaching. We should always consider the patient not only as a collection of symptoms, signs and pathological processes but also as an individual with emotions, problems and moral standards. Biomedical ethics is an integral part of such care. Familiarity with basic bioethical principles (Table 1) is as essential for the practice of medicine as the knowledge of pathophysiology is for the understanding of the disease process.